Health TrialsbyHealthPanel

Comparison of Two PPOS Models for Pituitary Suppression

ConditionsInfertility, FemaleFertility Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-34
SponsorNextFertility

About this trial

The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI of 18-29,9 kg/m2

Ultrasound count of antral follicles prior to COH ≥ 12 follicles

Meeting the criteria for inclusion in the egg donation program

Normal karyotype and no active sexually transmitted diseases

Disqualifiers

Patients excluded from the egg donation program

Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV

Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis.

Oligomenorrhea (<1 menstrual cycle in 3 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cerazet

    Drug

    Comparation of the utilization of two distinct progestogens for pituitary suppression

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Group DSG: DesogestrelActive comparator 1 intervention
Group B: Group MPA: MedroxyprogesteroneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total number of oocytes retrieved from follicular puncture

The total number of oocytes retrieved from the follicular puncture shall be counted.

Time frame
5 months
2

Number of mature oocytes (MII) retrieved from follicular puncture

The number of mature oocytes (MII) recovered from the follicular puncture shall be counted.

Time frame
5 months

Secondary outcomes

1

Oocyte quality variables

Oocyte morphology will be assessed following the standard grading system established in Next Fertility, according to the criteria mentioned above.

Time frame
5 months
2

Ovarian sensitivity index (OSI

total dose of gonadotrophin used/total number of MII oocytes obtained) x 1000

Time frame
5 months
3

Follicles

Number of basal antral follicles of each size at the time of starting COH, Total number of follicles on the day of the second control and Number of follicles at the time of administering the trigger.

Time frame
5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NextFertility

Lead sponsor

SINAE SL

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: